Mycelex

Clotrimazole is used for the treatment of local fungal infections due to Candida albicans, including the following:

• vaginal yeast infections ,
• oral thrush,
• tinea versicolor,
• tinea pedis ("athlete's foot"),
• tinea cruris ("jock itch") or
• tinea corporis.

• Athlete's Foot
• Ringworm
• Sickle Cell Disease (Sickle Cell Anemia)
• Thrush (Oral Candidiasis)
• Yeast Infection (in Women and Men)

Serious side effects have been reported with topical clotrimazole cream and solution including the following:

• Local irritation at the site of application, including burning, itching, redness, and swelling of the skin.
• Fever

Serious side effects have been reported with clotrimazole lozenges including the following:

• Nausea
• Vomiting
• Unpleasant mouth sensations
• Itching in the mouth

Do not use clotrimazole if you:

• are allergic to clotrimazole or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of clotrimazole, there are no specific foods that you must exclude from your diet when receiving this medication.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication

Topical cream:

The recommended dose of clotrimazole cream and solution for the treatment of skin infections is 1% cream or solution massaged into the affected skin twice daily for two to eight weeks.

Oral lozenges:

The recommended dose of clotrimazole lozenges for the treatment of yeast infections of the mouth is the use of one lozenge five times daily for fourteen days.  The recommended dose of clotrimazole lozenges for the prevention of yeast infections of the mouth is the use of one lozenge three times daily for the duration of a patient’s immunocompromised state, such as during chemotherapy, radiotherapy, or steroid therapy. 

If you use too much clotrimazole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If clotrimazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Mycelex, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Mycelex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Mycelex (clotrimazole cream, ointment, and solution).

Review Date: October 4, 2017

Each Mycelex® Troche contains 10 mg clotrimazole [1-(o-chloro-α,α-diphenylbenzyl) imidazole], a synthetic antifungal agent, for topical use in the mouth.

Structural Formula:

Chemical Formula:
C22H17CIN2

The troche dosage form is a large, slowly dissolving tablet (lozenge) containing 10 mg of clotrimazole dispersed in dextrose, microcrystalline cellulose, povidone, and magnesium stearate.

Abnormal liver function tests have been reported in patients treated with clotrimazole troches; elevated SGOT levels were reported in about 15% of patients in the clinical trials. In most cases the elevations were minimal and it was often impossible to distinguish effects of clotrimazole from those of other therapy and the underlying disease (malignancy in most cases). Periodic assessment of hepatic function is advisable particularly in patients with pre-existing hepatic impairment.

Since patients must be instructed to allow each troche to dissolve slowly in the mouth in order to achieve maximum effect of the medication, they must be of such an age and physical and/or mental condition to comprehend such instructions.

Carcinogenesis:

An 18 month dosing study with clotrimazole in rats has not revealed any carcinogenic effect.

Usage in Pregnancy: Pregnancy Category C:

Clotrimazole has been shown to be embryotoxic in rats and mice when given in doses 100 times the adult human dose (in mg/kg), possibly secondary to maternal toxicity. The drug was not teratogenic in mice, rabbits, and rats when given in doses up to 200, 180, and 100 times the human dose.

Clotrimazole given orally to mice from nine weeks before mating through weaning at a dose 120 times the human dose was associated with impairment of mating, decreased number of viable young, and decreased survival to weaning. No effects were observed at 60 times the human dose. When the drug was given to rats during a similar time period at 50 times the human dose, there was a slight decrease in the number of pups per litter and decreased pup viability.

There are no adequate and well controlled studies in pregnant women. Clotrimazole troches should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Safety and effectiveness of clotrimazole in children below the age of 3 years have not been established; therefore, its use in such patients is not recommended.

The safety and efficacy of the prophylactic use of clotrimazole troches in children have not been established.

GERIATRIC USE

Clinical studies of clotrimazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.